(28 days)
Not Found
No
The summary describes a surgical system for spinal fusion, focusing on mechanical components and surgical technique. There is no mention of AI or ML in the intended use, device description, or any of the provided sections.
Yes
The device is indicated for treating various spinal conditions, including pseudoarthrosis, spinal stenosis, and degenerative disc disease, by performing fusion and providing anterior supplemental fixation.
No
The device is described as a system for performing surgery (fusion, discectomy) and implanting devices, not for diagnosing conditions.
No
The device description explicitly states it is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The TranS1® AxiaLiF® System is a surgical implant and instrumentation used for spinal fusion. It is physically implanted into the body and used to manipulate and stabilize the spine.
- Intended Use: The intended use is for surgical procedures to treat spinal conditions, not for analyzing biological samples.
The device is a medical device used in a surgical setting, not an in vitro diagnostic device used for laboratory testing.
N/A
Intended Use / Indications for Use
The TranS1® AxiaLiF® System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranS1® AxiaLIF® is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5 - S1 in conjunction with legally marketed facet or pedicle screw systems.
The intended use of the instrumentation kit is for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy or for assistance in the performance of L5 - S1 interbody fusion.
Product codes
KWQ, HRX
Device Description
The TranS1® AxiaLIF® System is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. This device includes instruments for creating a small pre-sacral axial track to the L5 -- S1 disc space. The track and the device's instruments are used for distracting the L5 - S1 vertebral bodies and inserting bone graft material into the disc space. The device also includes an anterior fixation rod that is implanted through the same track.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine at L5 - S1
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
TranS1® Axial Fixation System, K050965 and K040426
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains a sequence of alphanumeric characters, specifically "K073514". The characters are written in a handwritten style, with varying stroke thicknesses. The characters are all connected, and the overall appearance is somewhat rough.
Image /page/0/Picture/1 description: The image shows the logo for "Tran$1". The logo is in black and white, with the text "Tran$1" in a bold, sans-serif font. The "$" symbol is used in place of the letter "s". There is a curved line extending from the bottom of the "1" and a registered trademark symbol next to the "1".
Premarket Notification [510(K)] Summary (per 21 CFR 807.92)
**
12 December 2007
| Submitter: | Contact Person: |
|---|---|
| TranS1, Inc. | William Jackson |
| 411 Landmark Drive | Vice President, RA, CL, QA |
| Wilmington, NC 28412 | 910-332-1700 (phone) |
| 910-233-7105 (fax) | |
| Proprietary Name: | TranS1® AxiaLIF® Fixation System |
| Classification: | Spinal Intervertebral Body Fixation Orthosis |
| 21 CFR 888.3060 | |
| Product Code: KWQ | |
| Arthroscope | |
| 21 CFR 888.1100 | |
| Product Code: HRX |
Predicate Device:
TranS1® Axial Fixation System, K050965 and K040426
Intended use:
The TranS1® AxiaLiF® System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranS1® AxiaLIF® is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5 - S1 in conjunction with legally marketed facet or pedicle screw systems.
The intended use of the instrumentation kit is for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy or for assistance in the performance of L5 - S1 interbody fusion.
Device Description
The TranS1® AxiaLIF® System is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. This device includes instruments for creating a small pre-sacral axial track to the L5 -- S1 disc space. The track and the device's instruments are used for distracting the L5 - S1 vertebral bodies and inserting bone graft material into the disc space. The device also includes an anterior fixation rod that is implanted through the same track.
Technological Characteristics and Substantial Equivalence
The technological characteristics of the TranS1® AxiaLIF® System have not changed.
f
00059
JAN 1 1 2008
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the symbol. The caduceus is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
Public Health Service
JAN 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TranS1, Inc. % Mr. William Jackson Vice President, RA, CL, QA 411 Landmark Drive Wilmington, NC 28412
Re: K073514
Trade/Device Name: TranS1® AxiaLIF® System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO, HRX Dated: December 12, 2007 Received: December 14, 2007
Dear Mr. Jackson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 -- Mr. William Jackson
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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Statement of Indications for Use
510(k) Number (if known):
Device Name: TranS1® AxiaLIF® Fixation System
Indications for Use:
The TranS1® AxiaLIF® System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranS1® AxiaLIF® is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5 - S1 in conjunction with legally marketed facet or pedicle screw systems.
The intended use of the TranS1 Trans-Sacral Spinal Access and Preparation Device is for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectorny or for assistance in the performance of L5-S1 interbody fusion.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Harbare Buem
(Division Sign-Off)
eral, Restorative. and Neurological Devices
510(k) Number K073514
Page 1 of 1
Special 510(k) AxiaLIF System